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PROVE Letter to Board of Health - Objections to Final Rules for Immunization Tracking

November 19, 1998

Texas Board of Health
1100 West 49th Street
Austin, TX 78756

Subject: Objections to Final Rules for Immunization Tracking

Dear Texas Board of Health,

Holding TDH accountable to write rules to comply with the legislation has taken a tremendous amount of work for parents and legislators. While I am encouraged by many of the changes to this 3rd set of rules, there is still one section of the rules which is in complete lack of reverence for the legislative intent of H.B. 3054.

I am respectfully requesting the board to amend the rules to correct the following problematic sections.

PROBLEM SECTION: Sec.100.2 (b) "At birth, parents will be able to consent for the child's future immunization history to be included in the immunization registry by indicating approval on the birth certificate." It is clearly shown below that immunization registry consent does not belong on the birth certificate.

SOLUTION: Delete Sec. 100.2 (b) removing immunization registry consent from the birth certificate.

The Board may not be aware that TDH has already been using the birth certificate to circumvent the collection of consent in a manner consistent with the requirements of H.B. 3054.

Item 19(b) on the Texas birth certificate application, to which section 100.2 (b) in the rules refers, reads "I consent for my baby's immunization information to be included in the statewide immunization registry and to share the immunization information with registered providers" and is followed by a "yes" and a "no" check box.

The first set of proposed rules were withdrawn earlier this year largely in part because they asked for parents to "decline" participation in the registry. During the first comment period, many senators and representatives reinforced with their letters that this legislation intended for the registry to be operated as an "opt-in" program only. The legislation requires the burden of action on TDH to obtain consent, not for the parent to decline consent. Consent obtained in this manner on the birth certificate pressures a parent who doesn't want to participate in the registry to "opt-out". This recording is permanent and tied to the child's birth record on file at the Bureau of Vital Statistics. Legislators and parents have consistently opposed any implementation that would allow TDH to keep track of "non-consenting" parents.

Sec.161.007 of the statute requires TDH by rule to develop guidelines to inform a parent about the registry and require the written consent of a parent before any information relating to the patient is included in the registry.

The legislature clearly intended for this written consent to be informed, however, there are no other statements about the registry on the birth certificate. TDH has readily acknowledged the lack of disclosure of information on the Vaccine Information Statements (VIS) currently being used and has even admitted to instructing providers to "destroy and recycle" these forms (page Final Preamble-10) as new ones with expanded information are provided. The rejected VIS forms contain a limited consent statement almost identical to the one TDH is trying to get away with on the birth certificate. I was told by legal counsel to TDH that adding to the information on the birth certificate was not even an option because of limited space. Although TDH may attempt to rationalize their actions by promising to make separate educational materials about the registry available, they haven't done it yet, and even if they do, TDH cannot guarantee that parents will have that information before or during the time they are asked to check "yes" or "no." The consent statement belongs with the disclosure information and a separate signature block.

The statute, in Sec. 161.008 (c) (2) requires the written consent of the parent to "release the data constituting an immunization record for the child to a public health district, a local health department, a physician to the child, or a school or child care facility in which the child is enrolled." Another shortcoming of the consent language on the birth certificate is that it only discloses that data will be released to providers, not health departments, schools, or day care facilities. TDH is vulnerable to legal action when parents learn that TDH has released their child's confidential medical information to recipients they have not consented to.

One very significant problem with obtaining consent in a "yes" or "no" check box format on the birth certificate is that birth certificate applications are first filled out by hand by a parent, and then the staff at the birth facility retypes it. I have been contacted by parents from around the state who have checked "no" only to find their final copy checked "yes." I even provided the Board with a letter from one parent this happened to in September. Additionally, when a parent refuses to check either box, because no signature is required, they often find that clerical staff will assume oversight and check "yes" for them. Because consent on the VIS form is represented by separate signature block, this extra level of administrative error does not occur. This makes the VIS forms a more accurate consent vehicle.

I am sympathetic to TDH's desire to start the tracking file at birth, and I would like to reassure the Board that TDH is already accomplishing this goal without Section 100.2 (b) on the birth certificate. Because the hepatitis B vaccine is administered at birth and the parents are required to fill out one of TDH's newly edited Vaccine Information Statements which includes consent for the registry anyway, a parent is able to consent to the registry with the full consent disclosure language referred to in the rules 100.2 (a) (2) and satisfying the statutorily required written informed consent of H.B. 3054. Deleting section 100.2 (b) will preserve the integrity of the legislative intent of an "opt-in" program and written informed consent, eliminate the waste of redundant collection procedures, substantially reduce clerical errors of assuming consent, and still allow TDH to obtain consent to the registry at the time of birth.

PROBLEM SECTION: 100.2 (a) (2) "I authorize the Texas Department of Health's Immunization Registry to release past, present, and future immunization records on my child to a parent and any of the following:."

SOLUTION: Change the words "a parent" to "his parent."

This is probably an unintentional oversight, however, this language allows for the interpretation of permission to release of a child's immunization record to anybody who is a parent, not just the child's parent.

OVERALL PROBLEM: There is not a SINGLE entry in the registry today that has been collected in compliance with the full consent requirements of H.B. 3054. This includes the entries TDH desires to "grandfather" into the registry, referred to in the rules as Sec. 100.6, as well as all children's immunization histories collected by TDH since September 1997 - the effective date of the legislation requiring written informed consent.

I understand this places the Board of Health in a tough predicament. On one hand, it does not make sense to delete the information of those families who desire to participate in the registry. That would be unfair to them and wasteful. On the other hand, what type of message will the Board of Health be sending to Texas citizens by allowing this state agency to collect and maintain confidential medical information obtained against parents wishes and in violation of the legal protections voted in by our legislature and signed by our Governor into law? The taxpayers of this state have already wasted enough money on TDH's attempts to circumvent the law, and any correction to this problem will result in more money spent, however, we can't afford to ignore that an expensive lawsuit filed against TDH will most likely be the result of no measures taken to correct this problem.

Attached is a copy of the consent form TDH has used to FORCE a parent to consent to the registry when they consent to vaccinate. One of these forms must be filled out every time a vaccine is given and all vaccines have a form worded identically to this one. As you can see on this form, TDH does not recognize the legal right of a parent to consent to immunization and not be put in the registry. Additionally, many parents have contacted me who have left the doctor or clinic office without giving their child a vaccine because they did not want to give consent to the registry. Even though TDH will begin using new forms after the rules are finalized to correct this problem, that does not excuse ignoring a parent's right to not be included in the registry for the last 14 months the law has been in effect.

TDH's proposal of supplying doctors with a poster that will most likely never be seen is too little too late. Please do not forget that TDH has been operating the registry for years prior to legislative authority. It had illegally populated the registry with demographic data on almost 3/4 of a million children obtained without any parental consent from the Bureau of Vital Statistics. This data has been deleted because of pressure put on by legislators when I found that TDH had done that with my daughter.

It is clear to everyone now that the legislature intended for this registry to be a voluntary "opt-in" registry. Regardless of whether one is for or against the idea of the government operating medical databases on private citizens, TDH's continued unwillingness and inability to treat confidential medical information with respect demands that the privilege granted by the Texas Legislature to operate such a powerful system be reconsidered.

Dawn Richardson

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